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CBD Science Group aiming to show the value of real-world data as it develops pioneering cannabis-derived pain relief for people with cancer

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Researchers will look at a ‘more holistic data set’ than the simple pain scores used in traditional clinical trials when putting together its final submissions. The goal is to provide a more thorough assessment of the use of cannabis-based analgesics

 
If the pandemic has turned the world on its head, the transformation hasn’t entirely been for the worse.

The balance between work and home has been redressed (a little), our carbon footprint has shrunk (a tad), and a communications revolution has been spawned (thank-you Zoom).

Necessity was the mother of invention when it came to finding vaccines in a matter of months rather than years, and the UK led the way in this regard.

That the timeline was shortened so radically owed a lot to the new approach as regulators relied on real-world evidence when approving the Oxford-AstraZeneca jab on December 2, 2020.

Had the vaccine been forced down the traditional three-phase route of randomised clinical trials it may have taken up to a decade and cost hundreds of millions of pounds to bring the new drug to market.

Vaccine success sets the scene 

To be fair, the regulatory hoop-jumping is there for a reason. It exists to prevent a recurrence of drug scandals such as thalidomide that have scarred thousands of lives.

But in the grip of an international emergency, regulators in Britain accepted real-world data generated by human challenge studies where healthy adults were infected with Covid.

It is a change of tack that could irrevocably alter the landscape for those developing the next generation of drugs and treatments for the UK market.

In a nod to the streamlined process that got vaccines to the market in super-quick time, Britain’s regulatory authorities have said they are ready to accept real-world data in certain circumstances when approving treatments for use here in the UK.

Be in no doubt, this is a significant movement for both the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE).

CBD Science Group PLC, very aware of the direction of travel, believes this evidence-based regulatory approach will provide the key to unlocking the cannabinoid medicines it is pioneering.

Accelerated timeline 

“It has been made clear that Dr [June] Raine and her newly formed team at the MHRA are committed to an integrated process in coordination with NICE, to use real-world evidence; to accelerate, develop and deploy innovative medicines to rapidly improve patient access,” says Graeme McFarlane, the chief commercial officer of CBD Science.

“It’s clear that the lessons learnt from the Covid-19 vaccination programme are being applied for innovative medicines going forward”

The company is planning large-scale real-world evidence trials to assess the use of cannabinoids in cancer patients where traditional pain relief is not sufficient. This would offer an alternative to mainstay opioids, which potentially interfere with patients ongoing cancer treatment regimen or bring unwanted side effects.

Researchers at CBD Science will look at a ‘more holistic data set’ than the simple pain scores used in traditional clinical trials when putting together its final submissions. The goal is to provide a more thorough assessment of the use of cannabis-based analgesics.

“We’ll not only measure safety and efficacy, which is a must, but also look at other areas that are important to people,” explains McFarlane.

“We’ll be using a host of tools such as patient self-reporting, clinician reporting, as well as other tools to take into account wider wellbeing outcome.

“As well as this we’ll delve into the health economics of these medicines, assessing in economic terms the true value of these natural medicines.”

The alternative, which is randomised controlled trials (RCTs), are not designed to take in the wider datasets needed to understand and review a medicine’s performance in the real-world setting, McFarlane points out.

“We’ve seen it many times before, just because it [a drug] performs well in a clinical trial setting doesn’t mean it’ll perform well in the real world.”

CBD Science expects to start its trials in the second quarter of next year having secured a robust supply chain that will meet the requirements of these studies.

“They are going to be large-scale studies of between 100-200 patients initially, expanding to multiple centres in the UK and Europe. This is what’s needed for an effective real-world strategy,” says McFarlane.

The company hopes to release early outcome publications throughout the study.

This approach of continually updating on its work will provide “a great tool to educate clinicians and to continue improve access for the millions of people suffering”, the CBD Science chief operating office (COO) says.

It is likely they will have enough real-world evidence to submit to the UK regulatory bodies in the second quarter of 2023.

Crowdfunding underway 

Currently, CBD Science is crowdfunding to finance early trials and is aiming to raise £2mln.

Longer-term, it is likely to turn to the stock market for the capital required to expand and develop the business.

Lending their support to the company (and by extension providing third-party validation of its strategy) is a clinical advisory board that wouldn’t look out of place at a large-cap pharma company.

Top-notch advisors

It includes Professor Mike Bewick, former deputy medical director of NHS England, and Professor Sam Ahmedzai, the National Institute for Health Research’s lead for cancer. Also on board are leading experts in palliative care, pharmacology and anaesthetics.

“Ours is a unique strategy,” says Dr Michael Raymont, the chief executive of CBD Science. “And it is informed by a team of experts who want the best for patients and have an understanding of the regulatory framework.”

“Others are producing-high grade pharmaceutical [cannabis] products and hoping for regulatory change across the board.

“It is not going to happen until bodies such as NICE see the data. We are going to provide that data for our cannabinoid medicines for patients struggling with cancer pain.”

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